Gyun E Zero Sterilization Tissue: Package Insert and Label Information

GYUN E ZERO STERILIZATION TISSUE- isopropyl alcohol liquid
Sunmedical

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

ISOPROPYL ALCOHOL 70.0%(w/w)

INACTIVE INGREDIENTS

Water, EDTA-2Na, Sodium Benzoate, Methyl Propanediol, Caprylyl Glycol, Ethylhexylglycerin, Octyldodeceth-16

Purpose

Hand Sanitizer

Warnings

First Aid
1. Wash with clean water when it gets into your eyes, and consult your doctor if you have any problems.
2. Take emergency measures to eat or swallow contents and Consult a doctor immediately.

Precautions for Use
1. Please follow the indicated usage and standard usage.
2. Be careful not to let the contents touch your eyes.
3. Do not inhale or drink.
4. Ventilate enough when using in an enclosed space.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease.

■ Isopropyl alcohol is a typical raw material for disinfectants.

Directions

■ Take out one sheet and wipe where sterilization is required.

■ Close the cap after use.

PACKAGE LABEL — Gyun-e zero sterilization tissue (10pcs, 50g) NDC: 75578-020-01

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PACKAGE LABEL — Gyun-e zero sterilization tissue (75pcs, 580g) NDC: 75578-020-02

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GYUN E ZERO STERILIZATION TISSUE
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75578-020
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 70 g in 100 g
Inactive Ingredients
Ingredient Name Strength
Water
Sodium Benzoate
MethylPropanediol
CAPRYLYL GLYCOL
Ethylhexylglycerin
Octyldodeceth-16
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75578-020-01 50 g in 1 CONTAINER None
2 NDC:75578-020-02 580 g in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/01/2020
Labeler — Sunmedical (688954380)
Registrant — Sunmedical (688954380)
Establishment
Name Address ID/FEI Operations
Sunmedical 688954380 manufacture (75578-020)

Revised: 08/2020 Sunmedical

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